Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction

NCT03549260 | Completed Phase 2 FDA Drug

• 1 other identifier: LIB003-002
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 5

Brief Summary

Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy

Conditions

LDL Cholesterol

Keywords

low density lipoprotein cholesterol; PCSK9

Outcome Measures

Primary Outcomes (1)

• Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12

  Change in serum LDL-C from baseline after 12 weeks

  baseline to 12 weeks

Secondary Outcomes (5)

• The incidence and severity of treatment emergent adverse events (TEAEs)

  baseline to 12 weeks

• Percent reduction in apolipoprotein B (Apo B) at week 12

  baseline to 12 weeks

• Percent reduction in lipoprotein (a) [Lp(a)] at week 12

  baseline to 12 weeks

• Percent reduction in free PCSK9 at week 12

  baseline to 12 weeks

• Presence of anti LIB003 antibodies (ADAs)

  baseline to 12 weeks

Study Arms (3)

LIB003 150 mg or matching placebo

EXPERIMENTAL

SC LIB003 150 mg or placebo every 4 weeks

Biological: LIB003

LIB003 300 mg or matching placebo

EXPERIMENTAL

SC LIB003 300 mg or placebo every 4 weeks

Biological: LIB003

LIB003 350 mg or matching placebo

EXPERIMENTAL

SC LIB003 350 mg or placebo every 4 weeks

Biological: LIB003

Interventions

LIB003 BIOLOGICAL

LIB003 or placebo

LIB003 150 mg or matching placebo; LIB003 300 mg or matching placebo; LIB003 350 mg or matching placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older
• Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on AHA/ACC CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
• Body mass index (BMI) between 18 and 40 kg/m2

You may not qualify if:

• Females of childbearing potential not using or willing to use an effective form of contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy test at screening
• Homozygous familial hypercholesterolemia
• LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months
• Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
• Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
• Newly diagnosed or poorly controlled (HbA1c \>9%) type 2 diabetes
• Uncontrolled hypertension
• Moderate to severe renal insufficiency
• Elevated liver function test at screening
• Uncontrolled cardiac arrhythmia or prolonged QT on EKG
• A history of prescription drug abuse, illicit drug use, or alcohol abuse

Sponsors & Collaborators

• LIB Therapeutics LLC: lead
• Medpace, Inc.: collaborator

Study Sites (5)

Midwest Institute For Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Louisville Metabolic and Atherosclerosis Research Center

Louisville, Kentucky, 40213, United States

Location

Sterling Research Group

Cincinnati, Ohio, 45219, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Metabolic & Atherosclerosis Research Center (MARC)

Cincinnati, Ohio, 45227, United States

Location

Study Officials

• Evan A Stein, MD

  LIB Therapeutics LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind and Placebo-Controlled - Study drug administered by unmasked nurse who is not involved in any other aspects of the trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled trial to evaluate LDL-C reduction with 3 different doses of LIB003 compared to placebo

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 7, 2018
• Study Start: May 22, 2018
• Primary Completion: November 9, 2018
• Study Completion: November 30, 2018
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)